Delivery system for a medical device

ABSTRACT

The invention is directed to a delivery system for delivering a medical device. The delivery system includes an inner member having a proximal end and a distal end. The inner member defines a longitudinal axis between the proximal end and the distal end. A tip is formed at the distal end of the inner member. A bumper is freely disposed on the inner member. The bumper has a proximal end and a distal end. A seat is defined between the tip and the distal end of the bumper. Additionally, a sheath is disposed about the inner member, the sheath having a proximal end and a distal end. The sheath is movable from a first sheath position substantially covering the seat, and a second sheath position axially offset to expose the seat. The invention also includes a handle in contact with the proximal end of the inner member.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. U.S. ProvisionalApplication Ser. No. 60/695,498 filed Jun. 30, 2005, and is acontinuation-in-part of U.S. patent Ser. No. 10/932,964, filed Sep. 2,2004, which claims priority to U.S. Provisional Application Ser. No.60/499,075, filed Sep. 2, 2003 the entire contents of each isincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a delivery system for delivery of oneor more medical devices, such as a stent, stent-graft or filter.Particularly, the present invention is directed to a delivery systemincluding an inner member having a tip, a bumper freely disposed on theinner member, a sheath disposed about the inner member, and a handleattached to the inner member. The invention also includes a relatedmethod for assembling a delivery system.

DESCRIPTION OF RELATED ART

A variety of systems are known for intraluminal delivery of a medicaldevice within a patient. However, there remains a need for continuedimprovement of such known delivery systems.

An example of such a system is described in U.S. Pat. No. 6,425,898 toWilson et al., wherein a delivery system is provided having an innermember with a stop attached to the inner member. During deployment, thestop helps to “push” the stent out of the sheath during deployment, bypreventing the stent from migrating proximally within the sheath duringretraction of the sheath for stent deployment. As with other systemsknown in the art, the system described by Wilson does not permitre-adjustment of the different components of the mechanism aftersterilization and shipment.

Conventional self-expanding stent delivery systems generally comprise ahandle portion and an elongated shaft, wherein the stent is disposedwithin a delivery portion at the distal end of the shaft. To deploy thestent, an outer sheath is retracted relative to the stent, whereby thestent is released from its delivery configuration. Shortcomings ofdelivery systems that operate in this manner is that the sheath isgenerally pulled back in a 1 to 1 ratio with the user's input, which fora longer stent requires a large amount of user input to release thestent which may lead to incorrect placement. Additionally, wheninitially releasing the stent, it is desirable to slowly pull back thesheath until a certain amount of the stent has been delivered and is incontacted the vessel wall, wherein it is then desirable to quicklyremove the sheath to prevent inadvertent movement of the stent.

Yet another shortcoming of present delivery systems is the amount offorce that is required to remove the sheath from the stent. Thereforethere is a need for an improved delivery system for self-expandingstents having reduced force requirements for delivery of aself-expanding stent.

There thus remains a continued need for an efficient and economic systemfor delivering a medical device that is easy to use and providesaccurate stent placement. The present invention satisfies these andother needs.

SUMMARY OF THE INVENTION

The purpose and advantages of the present invention will be set forth inand apparent from the description that follows, as well as will belearned by practice of the invention. Additional advantages of theinvention will be realized and attained by the methods and systemsparticularly pointed out in the written description and claims hereof,as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the invention, as embodied and broadly described, the invention isdirected to a delivery system for a medical device. The delivery systemincludes an inner member having a proximal end and a distal end. Theinner member defines a longitudinal axis between the proximal end andthe distal end. A tip is disposed at the distal end of the inner member.A bumper is disposed on the inner member. The bumper has a proximal endand a distal end. A seat is defined between the tip and the distal endof the bumper. The bumper includes a sleeve member, the sleeve memberhaving a length and a tubular wall. A sheath is disposed about the innermember. The sheath has a proximal end and a distal end. The sheath ismovable from a first sheath position substantially covering the seat,and a second sheath position axially offset to expose the seat. A handleis connected to the proximal end of the inner member. An actuator isdisposed on the handle to move the sheath with respect to the innermember along the longitudinal axis from the first sheath position to thesecond sheath position.

The actuator includes a first gear to provide a first deployment ratefor movement of the sheath and a second gear to provide a seconddeployment rate for the movement of the sheath.

In one embodiment, the first deployment rate is greater than the seconddeployment rate. The first gear is a sun gear. The second gear is atleast one planetary gear. The first gear is be operatively coupled to acourse adjust element, such as a thumbscrew, and the second gear may beoperationally attached to a fine adjust element. Preferably, threeplanetary gears are provided.

In another aspect of the invention, the actuator is configured to movethe sheath from the first sheath position to the second sheath positionat a ratio greater than one to one. The ratio of the first gear and thesecond gear may be 3:1 or 2:1 or another desired ratio.

In another aspect of the invention, the inner member is a tubular memberhaving a proximal end, a distal end, and a length therebetween.

In another aspect of the invention, the sleeve member of the bumper isformed of a flexible metallic element disposed along at least a portionof the length of the inner member. The bumper may further include anouter layer over at least a portion of the flexible metallic element.The bumper may define a first portion along the length of the innermember having a first diameter and a second portion along the length ofthe inner member having a second diameter. The first diameter is greaterthan the second diameter. The first diameter is defined by the innermember and bumper combined, and the second diameter is defined by theinner member. In another embodiment, the second diameter defines theseat. In yet another embodiment, the inner member defines a guidewirelumen along a length thereof. In another preferred embodiment, the innermember is formed of a lubricious material.

In another preferred embodiment, the outer layer is formed from apolymeric material. The flexible metallic element is a braid or coilelement.

In another aspect of the invention, the bumper is freely disposed on theinner member.

In another aspect of the invention, the delivery system further includesa hypotube disposed about the inner member. The hypotube has a distalend and a proximal end. The distal end of the hypotube is proximal tothe proximal end of the flexible metallic member.

In another aspect of the invention, the distal end of the bumper isconfigured to receive and radially constrain a proximal end of a stentdisposed within the seat. In another embodiment, the distal end of thebumper includes a conical configuration, or the like. Alternatively, thedistal end of the bumper includes at least one substantially rigidprojection.

In accordance with another embodiment of the invention, the sheathincludes an inner surface and an outer surface that define a wallthickness therebetween. The wall thickness is greater at the distal endthan the proximal end. The wall thickness is tapered between the distalend and the proximal end.

In another embodiment, the sheath includes an outer wall and a liner.The liner has an inner surface and an outer surface defining a wallthickness therebetween. The wall thickness is greater at the distal endthan the proximal end. The outer surface of the liner is secured to aninner surface of the outer wall. In another embodiment, the innersurface of the liner is lubricious.

In still another aspect of the invention, the delivery system alsoincludes a lock having an unlocked position. The unlocked positionpermits movement of at least one of the actuator and sheath. The lockedposition prohibits movement of the at least one of the actuator andsheath.

In another embodiment, the lock includes a locking lever operationallyengaged to the actuator and configured to releasably lock at least oneof the actuator and sheath, when in the locked position.

In yet another embodiment, the lock is operatively disposed to provideinitial movement of the sheath when the lock is moved from the lockedposition to the unlocked position. The lock includes a cam to cooperatewith the actuator to provide the initial movement. The locking lever ishingedly attached to the handle and further includes a detent configuredto engage the actuator to inhibit movement of the sheath.

In another embodiment, the tip includes a stent retention feature. Theretention feature including a recess to receive and radially constrain adistal end of a stent disposed in the seat.

In another embodiment of the invention, the delivery system for deliveryof a medical device is configured to include an inner member having aproximal end and a distal end. The inner member defines a longitudinalaxis between the two ends. A tip is disposed at the distal end of theinner member. A bumper is disposed on the inner member. The bumper has aproximal end and a distal end. A seat is defined between the tip and thedistal end of the bumper. The bumper includes a sleeve member and thesleeve member has a length and a tubular wall. A sheath is disposedabout the inner member. The sheath has a proximal end and a distal end.The sheath is movable from a first sheath position substantiallycovering the seat to a second sheath position axially offset to exposethe seat. A handle is also provided to be in contact with the proximalend of the inner member.

An actuator is disposed on the handle and is coupled to arack-and-pinion assembly to move the sheath with respect to the innermember along the longitudinal axis from the first sheath position to thesecond sheath position. The rack-and-pinion assembly is configured toincrease a deployment rate of movement for the sheath during at least aportion of movement of the actuator.

In one embodiment, the ratio of movement of the sheath to movement ofthe actuator is greater than 1:1 during at least a portion of movementof the actuator. In another embodiment, the ratio of movement of thesheath to movement of the actuator varies. In yet another embodiment,the ratio of movement of the sheath to movement of the actuator isconstant.

According to another embodiment, the rack-and-pinion assembly includes afirst gear rack, a second gear rack and a pinion gear. The first rack isdisposed at an angle less than ninety degrees relative to the secondrack. The first gear rack is moveable relative the second gear rack andthe pinion gear is operatively coupled to the first and second gearracks, respectively. In another embodiment, the first gear rack iscoupled with the sheath. In another embodiment, the actuator includes aslider operatively coupled with the pinion gear. Movement of the sliderengages the pinion gear along the second gear rack to rotate the piniongear, which in turn engages the first gear rack for linear movementthereof.

In yet another embodiment, the first rack includes a plurality of gearteeth along a length and the second rack includes a plurality of gearteeth along a length. The first rack has a different number of teeththan the second rack.

In accordance with another embodiment of they delivery system, the firstrack further comprises pins configured to be received within a trackprovided on the handle.

In another embodiment of the delivery system, the actuator includes aslider moveable in a linear direction. The slider has first and secondextenders extending therefrom. Each extender includes a slot definedtherein. The rack-and-pinion assembly includes a pinion gear having afirst end, second end and a plurality of gear teeth formed therebetween.The first and second ends of the pinion gear slidingly engage arespective one of the slots defined in the first and second extenders. Afirst rack having a first end and a second end and a plurality of gearteeth is formed therebetweeen. The first rack is operatively coupled tothe pinion gear. A second rack including a plurality of gear teethdisposed thereon is also provided. The plurality of gear teeth of thesecond rack operatively engage with the pinion gear. The engagement ofthe pinion gear along the second rack due to the movement of the sliderresults in movement of the first rack in the linear direction at a rategreater than the movement of the slider.

In another embodiment, the plurality of gear teeth disposed on the firstrack have a pitch different than the plurality of gear teeth on thesecond rack. In yet another embodiment, the second rack includes a pairof elongate members. Each elongate member has a plurality of teeth inengagement with the pinion gear. In another embodiment, the second rackis arc-shaped. In another embodiment, the deployment rate of the sheathis at least twice the rate of movement of the actuator.

In another embodiment, the rack-and-pinion assembly includes a pinionhaving a plurality of teeth along its length and a rack gear having acircumferential surface and being rotatable about a center axis. Therack gear has a first gear pitch operatively coupled with the rack and asecond gear pitch vertically displaced on a height of thecircumferential surface. The actuator includes a slider having anelongate surface with a plurality of teeth therealong. The plurality ofteeth of the slider are operatively coupled with the second gear pitchof the rack gear for rotation of the rack gear upon linear movement ofthe slider.

In another embodiment, the first gear pitch is defined by a firstgenerally cylindrical portion of the rack gear. The rack gear has afirst diameter and the second gear pitch is defined by a secondgenerally cylindrical portion of the rack gear having a second diameter.The first diameter is greater than the second diameter. Rotation of therack gear due to linear movement of the slider results in a greater rateof movement of the pinion.

In yet another embodiment, the pinion is operatively coupled to thesheath.

In another embodiment, the rack gear is a bevel gear that has agenerally conical circumferential surface. The second gear pitch isvaried along a height of the conical surface. The plurality of teeth ofthe slider are disposed at varied heights along the elongate surface.Linear movement of the slider results in varied engagement of theplurality of teeth along the height of the circumferential surface tovary the rate a rotation of the rack gear and the rate of movement ofthe rack.

In yet another embodiment, the plurality of teeth of the slider vary inpitch along a length of the elongate surface.

In another embodiment, the rack-and-pinion assembly includes a secondrack gear and the pinion is disposed between the first and second rackgear.

In further accordance with the invention, a method for delivering two ormore medical devices is provided. The method includes the steps ofproviding a delivery system for delivery of a medical device asdescribed above, introducing the delivery system into a patient;delivering a first medical device; moving the inner member with respectto the sheath; and delivering a second medical device.

In accordance with a further aspect of the invention, a method can beprovided wherein the first medical device and second medical device aredelivered without removing the delivery system from the patient.Additionally or alternatively, the tip can be brought into contact withthe distal end of the sheath during the inner member moving step. Themethod can further comprise the step of deploying a third medicaldevice.

In further accordance with the invention a method for assembling adelivery system for delivery of a medical device is provided. The methodincludes the steps of providing a sheath and a bumper. The methodincludes the step of positioning the bumper into the sheath. The methodfurther includes the steps of providing a medical device having aproximal end and a distal end and disposing the medical device in thesheath distal to the bumper, providing an inner member, and placing theinner member through the distal end of the sheath, and attaching ahandle to the inner member.

In further accordance with the invention, the bumper positioning stepcan include positioning the bumper into the distal end of the sheath.The inner member placing step can also include positioning the proximalend of the inner member through the medical device and the bumper.

In further accordance with the invention, the method can entail the stepof applying a lubricious material to the distal end of the sheath. Inaccordance with this aspect of the invention, the lubricious materialapplication step can include the step of applying a pressurized fluid tothe proximal end of the sheath to cause the lubricious material to coatthe medical device.

In accordance with another aspect of the invention, the method canfurther include the steps of providing a tip and positioning the tip onthe distal end of the inner member. The inventive method can alsoinclude the step of applying tension to the proximal end of the innermember to cause the distal end of the sheath to come into physicalcontact with the tip.

In accordance with still another aspect of the invention, the bumperproviding step can include the steps of providing a sleeve member,providing a radiopaque portion, and placing the radiopaque portion onthe sleeve member. The bumper providing step can also include the stepsof providing a covering member and disposing the covering member on thesleeve member and radiopaque portion.

In still further accordance with the invention, the method can furthercomprise the steps of providing an actuator and an adjustment member,and adjusting the position of the inner member relative to the sheathusing the adjustment member.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the invention claimed.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the delivery system, and method of the invention.Together with the description, the drawing serves to explain theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1( a) is a cross sectional view of a first representativeembodiment of the delivery system for delivering a medical device inaccordance with the present invention.

FIGS. 1( b)-1(d) are enlarged views of selected details of FIG. 1( a)

FIG. 2 is an alternative partial cross sectional view of a proximalportion of the device of FIG. 1.

FIG. 3 is an enlarged partial cross sectional view of a distal portionof an alternative embodiment of a delivery system in accordance with thepresent invention.

FIG. 4 is a partial cross sectional view of a distal tip portion of thedevice of FIG. 1.

FIG. 5 is a partial cross sectional view of a radiopaque marker band ofthe device of FIG. 1.

FIG. 6( a) is a fragmented perspective view of a bumper of the device ofFIG. 1.

FIG. 6( b) is a perspective view of an alternative embodiment of abumper of the device of FIG. 1.

FIG. 7 a is a plan view of a bumper of the device of FIG. 1.

FIG. 7 b is a plan view of an alternative embodiment of a bumper of thedevice in accordance with the present invention.

FIG. 7 c is a cross-sectional view of the alternative embodiment of thebumper taken about line 7 c of FIG. 7 b.

FIGS. 7D and 7E are partial cross-sectional views of an alternativeembodiment of a delivery system in accordance with the presentinvention.

FIGS. 8( a)-8(d) are a cross-sectional view, plan view and cutaway viewsof a sheath of the device of FIG. 1.

FIG. 8E is a cross-sectional view of an alternative embodiment of asheath in accordance with the present invention.

FIGS. 8F to 8G are cross-sectional views of alternative embodiments of asheath in accordance with the present invention.

FIG. 9A is an enlarged cross sectional view of a distal portion of thedevice of FIG. 1.

FIGS. 9B-D are cross-sectional views of a distal portion of the deviceillustrating stent retention mechanisms in accordance with the presentinvention.

FIG. 10 is a cross sectional view of an alternative embodiment of adelivery system in accordance with the present invention.

FIG. 11 is a partial cross sectional view of a proximal portion of analternative delivery system in accordance with the invention.

FIG. 12 is a cross sectional view of a proximal portion of analternative embodiment of a delivery system in accordance with thepresent invention.

FIG. 13 is a perspective view of an actuator lock of the device of FIG.1.

FIGS. 14( a)-14(c) are partial views of a stabilizer of the device ofFIG. 1 and two alternative embodiments, respectively.

FIG. 15 is a partial cross-sectional view of an alternative embodimentof a delivery system in accordance with the present invention.

FIG. 16 is a cross sectional view of an alternative nose design of thedelivery device in accordance with the present invention.

FIG. 17 a through 17 c are partial views of an alternative embodiment ofa sheath retraction mechanism in accordance with the present invention.

FIGS. 18 a through 18 c are partial views of an alternative embodimentof a sheath retraction mechanism in accordance with the presentinvention wherein the sheath is retracted in a non-linear manner.

FIGS. 19 a through 19 b are partial views of an alternative embodimentof a sheath retraction mechanism in accordance with the presentinvention.

FIGS. 20 a through 20 i are partial views of an alternative embodimentof a sheath retraction mechanism in accordance with the presentinvention.

FIGS. 21 a through 21 d are partial views of an alternative embodimentof a lock in accordance with the present invention.

FIGS. 22 a through 22 b are partial views of an alternative embodimentof a sheath retraction mechanism in accordance with the presentinvention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. The method and corresponding steps of theinvention will be described in conjunction with the detailed descriptionof the apparatus. The methods and apparatus presented herein are usedfor delivering a medical device, such as a stent, stent graft or filter,to a desired location in a patient.

In accordance with the invention, it is possible and desired to providea system for delivering such devices that is relatively inexpensive tomanufacture and easy to use.

For purpose of explanation and illustration, and not limitation, anexemplary embodiment of the delivery system for a medical device inaccordance with the invention is shown in FIGS. 1( a)-1(d) and isdesignated generally by reference character 1. This exemplary embodimentor portions thereof is also depicted in FIGS. 2, 4-6(a), 7-9, and13-14(a). Additional embodiments are shown in FIGS. 3, 6(b), 10-1214(b)-14(c) and 15 for purpose of illustration and not limitation.

A variety of types of medical devices are suitable for delivery by thedelivery system of the present invention. For purpose of illustrationand not limitation, medical device 400 is depicted herein as aself-expanding stent. Such devices are generally well known in the art.However, the delivery system 300 of the present invention is not limitedto the delivery of self-expanding stents. Other devices may also beused. For example, stent-grafts, coils, filters, balloon expandablestents, stent grafts, and embolic protection devices may be deliveredwithin a patient's vasculature using the delivery system 300 of thepresent invention. Other devices such as a prosthesis retrievalmechanism may also be delivered with the delivery system 300 to apredetermined location in a patient's luminal system. Moreover,combinations of medical devices and/or beneficial agents can also bedelivered using the device of the present invention. For example,multiple stents and/or a combination of stents and embolic protectiondevices and/or beneficial agents can be delivered using delivery system300 of the present invention, as described in detail below.

The delivery system in accordance with the present invention includes aninner member having a proximal end and a distal end, generally defininga longitudinal axis therebetween.

For purposes of illustration and not limitation, the inner member 10 isschematically depicted in FIGS. 1B, 9 and 10. Inner member 10 isgenerally a longitudinal elongate member having a proximal end 12 and adistal end 14 and a length therebetween. Preferably, inner member is atubular member having a cylindrical wall 16 that defines a lumen 18therethrough and having an inner surface 20 (See FIG. 1( b)). Lumen 18preferably traverses the entirety of the length of inner member 10, andis configured to permit passage of a guidewire (not shown) therethrough.Alternatively, the lumen may be defined only in the distal portion ofthe inner member to facilitate rapid exchange of a guidewire asdescribed further below.

Inner member 10 is preferably made from a polymeric material such asPEEK and preferably traverses substantially the entire length ofdelivery system 300. However, any of a variety of materials can be usedfor inner member 10. For example, inner member could be made from otherpolymers such as PTFE, PVDF, Kynar, or polyethylene of various suitabledensities. Alternatively, inner member could be made from a metallicmaterial, such as Nitinol or stainless steel. As a further alternative,inner member 10 can be a composite member comprising a fabrication ofseveral different materials, such as a co-extrusion of differentpolymers, or fiber-reinforced composite material such asfiber-reinforced resin material.

In accordance with an exemplary embodiment of the invention, suitabledimensions for inner member 10 include a length of about 60 inches, anexternal diameter of about 0.045 inches and an internal diameter ofabout 0.038 inches. It is recognized, however, that the dimensions willdepend on the intended or desired applications for the delivery systemand the above dimensions should not be considered limiting in anymanner.

Surface 20 of lumen 18 is preferably provided with a lubricious coating22 thereon, such as silicone or a suitable hydrophilic material tofacilitate passage of a guidewire therein. However, a variety ofcoatings and/or surface treatments can be used.

A variety of different configurations may be used for inner member 10.With specific reference to FIG. 3, in accordance with another exemplaryembodiment of the invention, a guidewire proximal port is provided arelatively short distance along the length of inner member 10. Inaccordance with this aspect of the invention, inner member 10 defines aguidewire exit port 11 near the distal end of delivery system 300 topermit entry and exit of a guidewire (not shown). A delivery system madein accordance with this aspect of the invention would be suitable foruse as a rapid exchange catheter, which offers the advantage of nothaving to use an elongated guidewire or guidewire extension, so as tofurther simplify the delivery procedure.

Further in accordance with the invention, a tip is located at orproximate the distal end 14 of inner member 10. FIG. 9A shows anexemplary embodiment of a tip in accordance with the invention.Preferably, the tip provides an enlarged cross dimension at or proximatethe distal end of the inner member, as will be described.

Tip 30 is preferably, although not necessarily, formed as a separatepiece from inner member 10. For purposes of illustration and notlimitation and as depicted in FIG. 4, tip 30 has a proximal end 32, adistal end 34, and has a generally cylindrical shape with asubstantially constant diameter section 36 and a distal tapered section38. Tip 30 is molded from a relatively soft material, which may besofter than inner member 10 so as to reduce trauma to the vasculature ofa patient. In accordance with a preferred embodiment of the invention,the tip is molded from a polyether block amide, sold under the tradename of PEBAX by Atofina Chemicals Inc. of Philadelphia, Pa. However,various other materials can be used for the tip as is known in the art.A preferred material is sold under the trade name of PEBAX 4033. It isfurther contemplated that the tip 30 may be made of a material that isharder and/or has greater stiffness than the inner member 10.

Preferably, distal end 34 of tip 30 is in longitudinal alignment withdistal end 14 of inner member 10. Having inner member 10 traverse theentire length of tip 30 provides for a smooth surface for a guidewire(not shown) to move against inside lumen 18. Alternatively, if adiscontinuity (not depicted) were present in lumen 18, such as if tip 30extended beyond distal end 14 of inner member 10, a guidewire couldcollide with the discontinuity.

Suitable dimensions of tip 30 can include a length of about 0.5 inches,a distal external diameter of about 0.06 inches and a proximal outsidediameter of about 0.08 inches, although actual dimensions will dependupon the intended application and the above dimensions should not beconsidered limiting in any manner and have been provided for exemplarypurposes.

Tip 30 can be formed as a single piece with inner member 10 or madeseparately and then attached using any suitable technique, such asfusion bonding, laser welding/curing, UV bonding, adhesive or the like.Tip 30 is preferably mounted on the distal end 14 of the inner member 10using an adhesive. In accordance with a preferred embodiment of theinvention, the tip 30 is mounted on the distal end 14 of inner member.Next, an adhesive primer is applied to the joint created betweenproximal end 32 of tip 30 and inner member 10 and is permitted to dry.Preferably, the primer is selected so as to wick into the joint betweenthe two components simply upon application. Next, an adhesiveaccelerator is applied to the joint and permitted to wick in and dry. Anadhesive is then applied in a similar manner. Optionally, at this point,the inner member can be placed in a heated environment for a period oftime sufficient to cure the adhesive. For example, the assembly can beplaced into an oven for about 1-10 minutes at a temperature betweenabout 50 and about 70 degrees centigrade. Preferably, the assembly iscured at about 57 degrees C. for about two minutes.

Preferred primer, accelerator and adhesive components include 7451Loctite® accelerator, 7701 Loctite® primer and 4014 Loctite® adhesivefrom Loctite Corporation, although others can be used. For example, a UVcured adhesive may be utilized for assembly.

For purposes of illustration and not limitation, as depicted in FIG. 5herein, the tip 30 may further define a distal radiopaque portion 40.Distal radiopaque portion 40 may be a sleeve member that is formedseparately from tip 30 and attached to the proximal reduced diameterportion 42, or may be formed integrally therewith. For example,radiopaque portion 40 can be formed by impregnating the polymericmaterial of tip 30 with radiopaque particulate such that the particulatebecome lodged in the polymeric structure. In this manner, it is possiblefor tip 30 to comprise a single integral piece. Alternatively, theradiopaque material can be applied as a coating or by other techniquesas described below. Suitable materials that may be utilized to form theradiopaque portion 40 may include: gold, silver, nickel, stainlesssteel, tantalum, platinum, iridium, cobalt or similar materials orcomposites thereof which have desirable radiopaque features.

In accordance with an exemplary embodiment of the invention, distalradiopaque portion 40 is provided as a composite sleeve comprisingplatinum and iridium. Suitable dimensions of such a markerband includean outside diameter of about 0.065 inches, an internal diameter of about0.062 inches, and a length of about 0.024 inches although the actualdimensions will depend on the intended application, wherein thedimensions above have been provided for exemplary purposes and shouldnot be considered limiting in any manner. Such a markerband can beattached to tip 30 in a variety of ways. For example, MasterbondEP3HTMED Epoxy available from Masterbond, Inc. or Loctite 4014 adhesivecan be used, although many other adhesives are appropriate and withinthe scope of the invention.

The delivery system in accordance with the invention further includes abumper. The bumper is freely disposed on the inner member.

For purposes of illustration and not limitation, bumper 50 isschematically depicted in FIGS. 6-7 b. Bumper 50 is generally alongitudinal sleeve member 51 including a proximal end 52 and a distalend 54, with a tubular wall 56 having inner surface 58 and outer surface60 defining a lumen 62 therethrough. As embodied herein, lumen 62 isconfigured to permit passage of inner member 10 therethrough. Sleevemember 51 is preferably made from a metallic material such as stainlesssteel or nickel-titanium alloy, but can be made from any suitablematerial of sufficient compressive strength and flexibility, such asselected polymeric materials. Preferably, sleeve member 51 is made from304 V stainless steel tubing. Further still, the bumper may beconstructed of multiple pieces that are assembled to form a longitudinalsleeve member as shown and described herein.

Bumper 50 may be further provided with a channel 53 as depicted in FIG.6( b), such that bumper 50 is provided with a “C”-shaped cross-section.Channel 53 can be used to facilitate the flushing of a liquid such assaline solution and/or a beneficial agent to the patient. By providingchannel 53, a larger flow channel is provided between inner member 10and sheath 90, thereby permitting more fluid to be delivered to thepatient with greater ease.

In further accordance with the present invention, the delivery systemfurther includes at least one seat that is defined between the tip andthe distal end of the bumper.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIG. 1( b), a seat 116 is defined between proximal end 32of tip 30 and the distal end 54 of bumper 50. Seat also occupies anannular space 118 defined between inner member 10 and sheath 90. Seat116 is sized and shaped to receive a medical device 400 thereon,discussed in detail below. Seat 116, and hence medical device 400 willbe exposed when a sheath, as will be described, is moved with respect toinner member 10 from a first sheath position substantially covering seat116 as depicted in FIG. 1( b), to a second sheath position axiallyoffset to expose seat 116.

For purposes of illustration and not limitation, as depicted in FIG. 15,in further accordance with the invention, delivery system 300 can beprovided with more than one seat 116 to permit delivery of more than onemedical device 400. In accordance with this aspect of the invention,more than one bumper 50 a-50 n can be provided defining more than oneseat 116 a-116 n, permitting delivery of more than one medical device400 a-400 n. The multiple medical devices can be delivered in closeproximity to one another, or further apart. If it is desired to delivereach of a plurality of medical devices to substantially displacedlocations, it is possible to deliver a first medical device 400, andrealign the distal end 98 of sheath 90 with tip 30, if desired, usingthe adjustment member 270 before moving delivery system 300 to adifferent location within the patient's vasculature system, as discussedin detail below. When more than one bumper 50 is provided, anintermediate bumper, such as 50 a or 50 b, can be provided with aradiopaque marker 76 a-n at each end to help aid in visualization anddelivery of the medical device 400 and/or placement of the deliverysystem 300 within a patient's vasculature system.

An additional restraining device (not shown) can also be provided toprevent axial movement and/or radial expansion of medical device 400.Such a device can include a membrane or resilient clip. It would also bepossible to provide seat 116 with a number of radial protrusions affixedthereto to prevent axial displacement of medical device 400 duringdelivery thereof. Further still, it is contemplated that after disposingthe medical device 400 within seat 116, a retaining agent may then bedisposed thereupon to aid in retaining the medical device 400 within theseat 116. The retaining agent may be configured to be dissolvable uponcontact with a fluid such as saline, blood or other biocompatible fluid.

Referring now to FIG. 9B, there is shown an alternative embodiment ofthe seat 116 of the present invention, wherein a stent retention feature31 is shown formed on the proximal end of the tip 30. A similarconically configured feature, or the like, is be formed on the distalend of the bumper 54. The retention feature includes a recess 31 toreceive and radially constrain a distal end of a stent disposed in theseat 116. The retention feature 31 is formed having first and secondangled surfaces and a generally flat section joining the two angledsurfaces. In use, the ends of the stent 405 are received by the firstand second angled surfaces, thereby compressing the ends of the stentand forming a space between the outer surface of the stent 400 and theinner surface of the sheath 90 as shown. The space formed between thestent and the sheath reduces friction forces between the stent andsheath during retraction of the sheath for delivery of the stent asdescribed in detail herein.

Another embodiment of the stent retention feature includes a thin rigidmember constraint attached to the distal end of the bumper. As embodiedherein and shown in FIG. 9C, the constraints can be configured as tworigid members 600 extending distally from the distal end of the bumper54. The rigid member 600 is configured to receive an end of the stent.Yet another embodiment is shown in FIG. 9D where the distal end of thebumper 54 is shaped to receive an end of the stent. It shall beunderstood that although the retention feature has been described withregard to specific geometric configurations these should not beconsidered limiting in any manner, and that other geometricconfigurations may be utilized to achieve the desired results describedherein.

For example and not limitation, the delivery system in accordance withthe present invention can be used for delivery of a self-expanding stenthaving eyelets disposed on the ends of the stent. If desired, thedelivery system can include a retention mechanism configured to receivethe eyelets of the stent in a contracted configuration to reducedelivery force.

In another aspect of the invention, as shown in FIGS. 7D and 7E, theinner member 10 is a tubular member having a proximal end, a distal end,and a length therebetween. The sleeve member of the bumper is formed ofa flexible metallic element 720 disposed along at least a portion of thelength of the inner member 10. As embodied herein, the bumper furtherincludes an outer layer 706 over at least a portion of the flexiblemetallic element 720. The bumper also define a first portion 714 alongthe length of the inner member having a first diameter and a secondportion 712 along the length of the inner member having a seconddiameter. The first diameter is greater than the second diameter.

As embodied in FIG. 7D, The first diameter is defined by the innermember 10 and bumper 50 combined, and the second diameter is defined bythe inner member 10. The second diameter defines the seat 716. As shownin FIG. 7B, the inner member 10 defines a guidewire lumen along a lengththereof. In a preferred embodiment, the inner member is formed of alubricious material. The inner member 10 can be secured to the bumper.

As embodied herein, the outer layer 706 is formed from a polymericmaterial. As shown in FIGS. 7D and 7E, the flexible metallic element isa braid or coil element.

In another embodiment of the invention, the bumper 50 is freely disposedon the inner member 10.

In further accordance with the invention, bumper 50 is configured tomove freely on inner member 10 with no points of fixation therebetween.Distal end 54 of bumper 50 abuts medical device 400. The proximal end 52of bumper may optionally abut a hypotube 250 (See FIG. 2). By permittingbumper 50 to move freely, it is possible to permit the longitudinalpositions of the various components (e.g., tip 30, medical device 400,bumper 50, hypotube 250) of delivery system 300 to be adjusted relativeto one another after receipt by the physician. Thus, when the deliverysystem is assembled with a medical device 400 thereon, it is possible tobuild up a desired longitudinal tolerance between tip 30, medical device400, bumper 50, and any other components that are disposed on innermember 10.

For purposes of illustration and not limitation, as embodied herein,tubular wall 56 of bumper 50 preferably has one or more perforations 64defined therein. As shown in FIG. 6( a), perforations 64 generally areoriented circumferentially about tubular wall 56. Preferably, inaccordance with this exemplary embodiment of the invention, theperforations 64 are disposed circumferentially about wall 56 in pairs soas to define hinge points 70 therebetween (See FIG. 7). As depicted,each perforation 64 subtends an angle of less than 180 degrees of thecircumference of cylindrical wall 56. However, a single perforationsubtending an angle greater than 180 degrees is also within the scope ofthe invention. Perforations 64 can be formed by laser discharge,milling, etching or any other suitable techniques.

Collectively, perforations 64 are preferably sized and shaped, andspaced from one another to modify the flexural characteristics of bumper50 in a predetermined manner without altering the compressibility ofbumper 50. For example, alternating pairs of perforations 64 can berotated with respect to each other by a predetermined angle, such as 90degrees as depicted in FIG. 6( a). In this manner, it is possible toprovide for enhanced flexure of bumper 50 in two directions that aresubstantially perpendicular to one another. Similarly, the longitudinalspacing between perforations can be varied to provide for varyingrigidity along the length of bumper 50. Likewise, the circumferentialplacement of perforations 64 about sleeve 51 can be varied to impartdesired bending characteristics to bumper 50.

In accordance with an exemplary embodiment, for purpose of illustrationand not limitation, sleeve member 51 has a total length of about 30inches and pairs of perforations are spaced from each otherlongitudinally by about 0.1 inches on center in a more distal portion ofsleeve member 51, and by about 0.2 inches on center in a more proximalportion of sleeve member 51. Additional spacings between perforationsalong the length of the sleeve member 51 may be implemented, if desired,to vary flexural characteristics gradually, or in a step like fashion.

There are many ways in which the perforations 64 can be shaped andarranged in accordance with the invention. For example, the perforationscan be varied in size and/or in longitudinal spacing to create regionsof greater or lesser axial flexibility. Furthermore, alternating pairsof perforations 64 need not be alternated merely by rotating them 90degrees. Any pattern of rotation to create a desired bendingcharacteristic can be achieved.

Moreover, the perforations do not need to be circumferentially alignedslit shapes. For example, and in accordance with an alternate embodimentof the invention as depicted in FIGS. 6-7 a, perforations 64 may includelongitudinal components, such as an I-shape. In accordance with thisaspect of the invention, perforations 64 include a circumferentialcomponent 66 and a longitudinal component 68. When arranged as shown inFIG. 7 a, perforations 64 define hinge points 70 therebetween.

A variety of other shapes and arrangements are possible for perforations64. For example, as depicted in FIG. 6, curved perforations can also beused. In accordance with this aspect of the invention, the perforationscan be ellipsoidal in shape (64 a) or could take the form of a curvedslot (64 b).

Referring now to FIGS. 7 b and 7 c, there is shown an alternativeembodiment of a bumper 50 in accordance with the present inventionwherein the bumper 50 includes a plurality of articulating joints 64 binstead of slots 64 as shown and described above with reference to FIGS.6-7 a. The articulating joints 64 b as shown in FIG. 7 b and 7 c, areconfigured to have male 164 and female 264 components, wherein the malecomponent 164 is configured to be received by the female component 264.The male and female components 164, 264 are retained by one another byan overlap of the wall thickness at the rounded portion of the jointbetween the male and female components as shown in FIG. 7 c, andreferenced by callout 65. The overlap can be described as being therelation of the tube circumference to the diameter of the circulardiameter of the male component. A preferred relation between thediameter of the male component and the circumference of the tube isabout 0.25. The connection between the male and female components maygain further support by overcoating or covering the plurality ofarticulating joints with a covering such as heat shrink tubing or thelike.

There are many ways in which the articulating joints 64 b can be shapedand arranged in accordance with the invention. For example, thearticulating joints can be varied in size and/or in longitudinal spacingto create regions of greater or lesser axial flexibility. Furthermore,alternating pairs of articulating joints 64 b need not be alternatedmerely by rotating them 90 degrees. Any pattern of rotation to create adesired bending characteristic can be achieved.

In yet another alternative embodiment, the bumper 50 may be formed ofone or more coil assemblies. It is contemplated that two coil assembliescan be utilized to form the bumper 50, wherein an inner coil is woundhaving a specific pitch and the outer coil is wound having a specificpitch, wherein the coils' pitches define flexible properties of thebumper 50. The flexibility of the bumper 50 may be further tuned oradjusted by varying the thickness of the material from which the coilassemblies are constructed of.

Ordinarily, if perforations 64 are provided, a physician must be carefulto ensure that all air is purged from delivery system 300 before it isintroduced into a patient, since introducing air into a patient's bloodstream can have dire consequences. Thus, in accordance with anadditional aspect of the invention, perforations 64 are filled in with afilling material that is flexible relative to the material that sleeve51 is made from. Examples of suitable materials include, but are notlimited to polymeric materials. Even more preferably, an elastomericmaterial can be used. By using a material that is flexible, theflexibility characteristics imparted to sleeve member 51 by perforations64 are not lost. The filling material can be molded over sleeve 51, forexample, in an overmolding process.

The filling material thus fills in the voids created by perforations 64that would otherwise be filled by air. By filling in perforations 64,the air is displaced, so air cannot become trapped in perforations 64when a physician flushes device 300 in preparation for a procedure.

Moreover, using a filling material can provide additional advantages.The filling material can include a beneficial agent. Such a beneficialagent can be delivered to a location inside of a patient, for example,by exposing perforations 64 containing the beneficial agent. If soconfigured, the filling material 64 will dissolve, thereby releasing thebeneficial agent into the patient's bloodstream. Optionally, a releaseagent can be flushed through device 300 such that, upon contacting thefilling material, causes the beneficial agent to be released into thepatient's bloodstream. Such a release agent can, for example, bedirected through flush port 240 (described in detail below) andsubsequently through channel 53 defined in bumper 50.

In accordance with another aspect of the invention, as embodied hereinand as depicted in FIGS. 5-6, a proximal radiopaque portion 76 can beprovided. As embodied herein, proximal radiopaque portion 76 is providedin the form of a markerband, similar to distal radiopaque portion 40.Proximal radiopaque portion 76 is disposed about, and preferablyattached to, distal end 54 of bumper 50. Attachment is preferablyprovided via adhesive bond. Suitable adhesives include, for exampleLoctite™ 4014 adhesive obtainable from Loctite Corp. Attachment may beaccomplished in other manners as well. For example, where proximalradiopaque portion 76 is provided as a metallic member, it can beattached to tubular wall 56 of bumper 50 by way of swaging, soldering,press fitting or brazing. If proximal radiopaque portion 76 is providedas a polymeric member containing radiopaque particulate material, it canbe molded over sleeve 56. Alternatively, a radiopaque dye can be applieddirectly to the sleeve member surface.

As with distal radiopaque portion 40, proximal radiopaque portion 76 cantake any one of a number of forms as described in detail above. Inaccordance with an alternative embodiment of the invention, proximalradiopaque portion 76 can be provided as a coating applied to bumper 50.For example, distal end 54 of bumper 50 can be coated with a radiopaquematerial such as silver, tantalum, gold, tungsten, platinum, iridium andthe like or any composites thereof. Similarly, distal end 54 can bedipped into a suitable radiopaque coating such as a polymer coating,having a radiopaque material entrained therein, or such a coating couldbe applied to bumper 50 by other methods including extrusion, sprayingor any other suitable method.

In accordance with an additional aspect of the invention, as depicted inFIG. 6( a), a covering member 80 is be provided for bumper 50. Asdepicted herein, covering member 80 has a proximal end 82, a distal end84, an exterior surface 86 and an interior surface 88. Preferably,covering member 80 is heat shrinkable tubing or the like, althoughalternative films of membranes can be used. The covering can be disposedabout the sleeve member.

Covering member 80 is preferably applied to sleeve 51 after affixingproximal radiopaque portion 76 thereto. With reference to the heatshrink embodiment of FIG. 6( a), covering member 80 is preferablyapplied to sleeve 51 in the following manner. First, a suitable lengthof heat shrinkable tubing, preferably exceeding bumper 50 in length, iscut and fit over sleeve 51, including proximal radiopaque portion 76 (ifprovided). Next, the covering member 80 is stretched from either endinto tension. The assembly including sleeve 51, proximal radiopaqueportion 76 and covering member 80 is subsequently brought incommunication with a heat source sufficient to cause covering member 80to shrink around sleeve 51. Once the heating step is completed, excesscovering material is trimmed from bumper 50.

Covering member 80 can take on a variety of forms. Although heatshrinkable tubing is depicted herein, using heat shrinkable tubing isnot necessary. In accordance with an alternative embodiment of theinvention, covering member 80 can be extruded over bumper 50.Alternatively, covering member 80 can take the form of a tape materialwrapped around bumper 50, and, if necessary, melted together to form acovering. In lieu of providing a separate radiopaque marker, distal end84 of covering member 80 can be impregnated with radiopaque material toform proximal radiopaque portion 76, described in detail above. Suitablematerials that can be used to form covering member 80 include, but arenot limited to heat shrinkable polymeric materials. It is furthercontemplated that the covering member 80 may be disposed upon the bumper50 through a dip coating, spray coating, extrusion, or other similarmanufacturing processes. The covering member 80 may impart mechanicalproperties, which are desirable to the functionality of the device; forexample, the covering member may include a friction reducing coating, abeneficial agent or other similar biocompatible coatings. Further still,the covering member may be constructed of more than one material alongthe length of the bumper.

The delivery system in accordance with the present invention furtherincludes a sheath disposed about the inner member, wherein the sheathhas a proximal end and a distal end. The sheath is movable between afirst sheath position substantially covering the seat, and a secondsheath position axially offset with respect to the first sheath positionto expose the seat.

For purposes of illustration and not limitation, as embodied herein,FIGS. 8( a)-8(b), show a representative sheath 90 having a proximalportion 92 terminating in proximal end 94, a distal portion 96terminating in distal end 98, an outer surface 100 and an inner surface102. Sheath 90 can extend over the entire length of inner member 10 oronly a portion thereof. Sheath 90 must be of a sufficient length tocapture medical device 400 in seat 116. Sheath 90 can be a single piececonstruction, or can be made from multiple pieces of material.

As shown in FIG. 8F, the sheath 90 is formed having a tapered profile.The sheath includes an inner surface 102 and an outer surface 100 thatdefine a wall thickness. In a preferred embodiment, the wall thicknessof the sheath is greater at the distal end than the proximal end.Wherein as shown in FIG. 8F, the inner surface 102 of the sheath 90would be contact with the stent 400 wherein the inner wall of the sheathproximal the seat 116 would be formed having a decreasing wall thicknessproximal toward the handle portion 120 of the device. By reducing thewall thickness of the sheath proximal to the stent, frictional drag canbe reduced during deployment of the stent by reducing and/or eliminatingcontact of the inner surface 102 of the sheath 90 with the bumper 50.

In yet another sheath embodiment, shown in FIG. 8E, wherein there isshown an exemplary cross-sectional view of an alternative sheath designin accordance with the present invention. As shown in FIG. 8E, the innerwall 102 of the sheath 90 is formed having a non-uniform surface. Asshown in FIG. 8E, the inner wall of the sheath is formed having arepeating pattern formed therein, the pattern forming a sinusoidalpattern about the inner circumference of the sheath 90. By forming theinner wall 102 in the manner shown in FIG. 8E, frictional forces betweenthe inner wall 102 of the sheath 90 and the outer surface of the bumper50 and the stent 400 can be reduced by forming points of contact betweenthe two surfaces instead of a continuous surface contact between the twosurfaces. The multiple contact points reduce friction between the sheathand the stent 400 as well as the bumper 50, thereby requiring less forceto retract the sheath during use. The sheath illustrated in FIG. 8E canbe fabricated as a unitary member or fabricated of more than oneelement.

In accordance with the invention, it is possible to provide sheath 90with varied stiffness (i.e., durometer) along its length. This may beaccomplished in a variety of ways. For example, proximal portion 92 ofsheath 90 embodied herein can include a first material and distalportion 96 of sheath 90 includes a second, different material at itsdistal end 98. In accordance with the invention, the sheath may alsodefine an intermediate region 104 wherein the first material is blendedwith the second material. For example, the first material can be a firstpolymer material and the second material can be a second, differentpolymer material. In accordance with an exemplary embodiment of theinvention, distal portion 96 of the sheath has a length of about 4inches, and sheath 90 has a total length of about 50 inches. It isunderstood that the dimensions of sheath 90 will depend on the intendedapplication.

The second polymer material incorporated into distal portion 96 ofsheath 90 can be less stiff than the first polymer material 94 inproximal portion 92 of sheath 90. For example, the first polymermaterial can include NYLON 12 and the second polymer material caninclude NYLON 68D. Other polymer materials however, may be used in lieuof or in combination with the above-described materials. For example, ablock copolymer material such as Pebax 7233 can be used. Alternatively,other materials such as polyvinylchloride (PVC) or polyurethanes can beused.

Variation in stiffness can be predetermined by blending the materials invarying proportions along the length of sheath 90 such that the majorityof material at the proximal end 94 of sheath 90 is NYLON 12 and themajority of material at distal end 98 of sheath 90 is NYLON 68. It isalso be within the scope of the invention to vary the rigidity of sheath90 by varying the diameter along the sheath.

Additionally or alternatively, the sheath 90 can define a first externaldiameter D1 at its proximal end 94, and a second, different externaldiameter D2 at its distal end 98. Preferably, the first diameter issmaller than the second diameter. For example, and in accordance with arepresentative embodiment of the invention, the sheath 90 can have a D1of about 5.5 French and a D2 of about 6.0 French, although thesedimensions can vary depending on the intended application. In accordancewith this aspect of the invention and as depicted in FIG. 8( a), a step106 is provided to allow for the change in diameter between the proximalend 94 and distal end 98 of sheath 90. Step 106 allows for the change indiameter to occur over a longer or shorter distance along sheath 90,depending on the application. Alternatively, a more gradual taper can beprovided if desired.

In accordance with another aspect of the invention, the sheath caninclude an outer layer and an inner layer.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIG. 8( c), sheath 90 can be provided with an inner layer110 attached to or formed with an outer layer 112. Preferably, innerlayer or liner 110 includes a lubricious material to facilitate thesliding of sheath 90 in a proximal direction when the medical device 400is deployed. For example, different types of polymers such as PTFE orhigh-density polyethylene (HDPE) can be used for the inner layer 110.Additionally, other lubricious polymers can be used. The outer layer 112preferably provides sufficient strength to capture a medical device 400therein, as well as allow movement between the first position and thesecond position. The multiple layers can be formed separately andadhered or bonded together or co-extruded as a single member.

In another embodiment as depicted in FIG. 8G, the inner layer can beformed as a liner 110 with a varied wall thickness. The liner has aninner surface 800 and an outer surface 802, thereby defining a wallthickness. The wall thickness has a greater width at the distal end thanthe proximal end. The outer surface 802 of the liner is secured to theinner surface 802 of the sheath 90. The inner surface 802 of the linermay be lubricious, as described above.

In further accordance with the invention and as depicted in FIGS. 8( c)and 8(d), sheath 90 can include a reinforcing layer 114 disposed betweenthe outer layer 112 and the inner layer 110. Preferably, the reinforcinglayer 114 includes braided material. For example, the reinforcing layer114 can be provided in the form of a braided stainless steel tube orsheet (See FIG. 8( c)). Preferably, the braid includes flattenedfilaments, as opposed to having filaments with a round cross-section.Although a metallic braided material such as that depicted in FIG. 8( d)is preferred, it is not necessary. It is also possible to provide a tubeincluding woven fabric or appropriately oriented filaments, such ascarbon fibers encased in a polymeric matrix. Likewise, such reinforcingfibers could additionally or alternatively be incorporated into innerlayer 110 and/or outer layer 112 during the manufacturing process. Thereinforcing layer 114 need not be present through the entire length ofthe sheath. For example, it is possible for reinforcing layer to beprovided along the proximal portion 92 of sheath 90 only, or somegreater or lesser portion.

In accordance with an exemplary embodiment of the invention, sheath 90has a wall thickness of about 6.0 mil, wherein inner layer 110 andreinforcing layer 114 have a thickness of about 2.0 mil, and outer layer112 has a thickness of about 4.0 mil. Wherein the dimensions above areprovided as examples and should not be considered limiting in anymanner.

When sheath 90 is provided with an inner layer 110, outer layer 112 anda reinforcing layer 114 sheath 90 is preferably formed in the followingmanner. First, inner layer 110 is formed through a tubular extrusionprocess, and disposed about a forming mandrel (not shown). The formingmandrel preferably has a shape that corresponds to the desired shape ofthe inside of the sheath 90. Next, reinforcing layer 114, preferablyprovided in the form of a stainless steel braid material, is positionedover a predetermined length of inner layer, preferably leaving a distalportion of the inner layer 110 uncovered by reinforcing material. Next,the outer layer 112 is extruded and positioned over the reinforcinglayer 114. Preferably, outer layer 112 is provided in the form of twoseparate tubular members that are overlapped slightly at their ends overreinforcing layer 114. Each portion of outer layer 112 can be adifferent material selected to provide a different durometer asdescribed above. The two portions of outer layer 112 can overlap by anamount such as about 0.1 inches. Next, a sleeve of heat shrinkablematerial is positioned over the entire sheath assembly. Finally, heat isapplied to the assembly. When heat is applied, the heat shrinkabletubing shrinks, and causes inner layer 110 to fuse with outer layer 112,trapping reinforcing layer 114 therebetween. The heating process alsocauses inner layer 110 to conform to the shape of the forming mandrel.Thus, if it is desired to have a sheath 90 with a varied and/or steppeddiameter as described above with regard to FIG. 6B, the mandrel can beformed accordingly. After the assembly cools, the heat shrinkable tubingis cut away, leaving behind sheath 90.

In further accordance with the invention, the delivery system includes ahandle connected to the proximal end of the inner member. The handle isused to manipulate the delivery system through a patient's lumen and todeploy the delivery system to deliver the medical device.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIGS. 1 and 2, handle 120 is connected directly to innermember 110 if desired or necessary. However, an indirect connectionthrough an intermediate coupling can be provided, as described in detailbelow. Handle 120 has a proximal end 122, a distal end 124 and anexternal gripping surface 126. Preferably, handle 120 is also providedwith an actuator 130 to move sheath 90 from the first sheath position tothe second sheath position, as discussed in detail below. When thedelivery system 300 includes an internal actuator mechanism 130 asdepicted in FIGS. 1-2, handle 120 can further include a nose piece 210,as discussed below.

Handle 120 is preferably formed of a plastic material, although othersuitable materials can be used. For example, handle 120 can be made fromABS plastic and/or polycarbonate and may include fiberglass fiberreinforcement. Optionally, gripping surface 126 may be enhanced byapplying a softer material thereto to enhance gripping. For example, acoating of rubber (not shown) or other similar elastic material can beused to enhance gripping and thereby make it easier for a physician totraverse the patient's vasculature using the delivery system.

In further accordance with the invention, an actuator can also beprovided. The actuator is disposed on the handle and is configured tomove the sheath with respect to the inner member along its longitudinalaxis 15 (See FIG. 1( a)) from the first sheath position to the secondsheath position, thus uncovering the seat to permit a medical devicecaptured or contained therein to be deployed.

As embodied herein, and in accordance with one aspect of the invention,actuator 130 can include a push-pull configuration as depicted in FIG.10. In accordance with this aspect of the invention, proximal end 94 ofsheath 90 is attached to actuator 130, and the proximal end 12 of innermember 10 is attached to handle 120. In accordance with this embodimentof the invention, Sheath 90 can be moved from the first sheath positionto the second sheath position by moving actuator 130 proximally, towardhandle 120. As actuator 130 is moved with respect to handle 120 seat 116is uncovered, thereby permitting medical device 400 to be deployed. Theratio of sheath movement to actuator movement can be greater than one toone.

This embodiment of the invention presents the advantage that theposition of inner member 10 and hence, the position of medical device400, remains stationary in the patient's vasculature as sheath 90 ismoved proximally. This permits precise placement of the medical device400.

Moreover, actuator 130 can take on a variety of different forms. Forpurposes of illustration and not limitation, in accordance with anotherembodiment of the invention and as depicted in FIG. 1( a), the actuator130 can include a rotatable member and shuttle assembly to translaterotational movement of the rotatable member into linear movement of thesheath.

In accordance with another embodiment, as shown in FIGS. 22 a and 22 b,the actuator includes a planetary gear train 900 to longitudinallyretract the sheath. The planetary gear train, as known in the art,generally includes at least one planetary gear 902 attached to a carrierplate 906 and operationally engaged to a ring gear 908, and a sun gear904 operationally engaged to each of the at least one planetary gear902. Each of the gears include teeth along their outer surfaces. A gearratio of this embodiment can be 3:1 or 2:1 or any other desired ratio.The sun gear 904 is operationally attached to a coarse adjust element910, such as a thumbscrew, and each of the at least first and secondplanetary gears 902 is operationally attached to a fine adjust element912. As embodied herein, three planetary gears are provided.

The planetary gear train (or set) 900 provides a mechanical advantage tothe user. The gear ratio provides this advantage. The ratio depends onthe number of teeth on the ring gear 908 compared to the number of teethon the sun gear 904. For example, if there are 60 teeth on the ring gearand 30 teeth on the sun gear, the gear ratio is one plus 60 divided by30 (which is 3) or 3:1. The planetary gear train 900 allows for multipledeployment speeds for the stent. The gear train 900 may be locatedeither in the front or the back of the handle.

A first gear provides a first deployment rate for movement of the sheathand a second gear provides a second deployment rate for the movement ofthe sheath.

In accordance with this aspect of the invention, sheath 90 can beadvanced proximally with respect to inner member 10 to uncover seat 116.

The proximal end 94 of sheath 90 is preferably attached, either directlyor indirectly, to a shuttle 140, wherein shuttle 140 is configured totravel in a shuttle guide 160. As embodied herein, shuttle 140 has aproximal end 142, a distal end 144, an external surface 146 and a lumen148 defined therethrough. Lumen 148 has a proximal section 150 and anenlarged distal section 152. Distal section 152 of lumen 148 is sized toreceive proximal end 94 of sheath 90. Sheath 90 is preferably attachedto shuttle 140 by way of adhesive bonding, although alternativeattachment techniques can be used such as fusion bond or force fit. Whenan adhesive bond is used, glue ports 151 are preferably provided forinjecting an adhesive material, such as Loctite 4014, into section 152.Shuttle 140 is further provided with a proximal groove 154 and a distalgroove 156 (See FIG. 2), each of which are configured to receive ano-ring 158. O-rings 158 are configured to prevent flushing liquid fromflowing into handle 120 as discussed below in the discussion of flushport 240. An additional inner seal 153 (see FIG. 1( d)) is provided inproximal section 150 of lumen 148 proximal to flush port 149 to sealbetween shuttle 140 and hypotube 250.

Shuttle 140 is preferably made of a moldable polymeric material withreinforcement fibers. For example, shuttle 140 can be made from amixture of nylon 66 and fiberglass, although other suitable materialscan be used.

Preferably, shuttle 140 is provided with rails 145 formed thereon (notshown) that are configured to ride in longitudinal slots 162 in ashuttle guide 160 to permit axial movement but not rotational movementof the shuttle 140. Shuttle 140 is further provided with a protuberance147 thereon. Protuberance 147 is configured to mate with a helical guidegroove 176 in thumbscrew 170 (See FIG. 2). Thumbscrew 170 has a proximalend 172, a distal end 174, and an exterior surface 178. Thumbscrew 170is attached at its distal end 174 to proximal end 182 of knob 180.Attachment is preferably achieved by adhesive connection, but may alsobe achieved by way of bonding, welding, snap-fit, force-fit or threadedconnection. Knob 180 and thumbscrew 170 thus cooperate to form athumbscrew assembly 188 (See FIG. 1( a)), and are configured to rotateabout shuttle guide 160. Thumbscrew 170 and knob 180 are preferably madefrom a polymeric material such as ABS plastic via injection molding.

In operation, when a user rotates knob 180 and thumbscrew 170 about thelongitudinal axis of the delivery system 300, protuberance 147, andhence, shuttle 140 with sheath 90 attached thereto is advanced in aproximal direction, withdrawing the distal end 98 of the sheath andexposing seat 116. It is further contemplated that the helical groove176 may be formed having more than one thread pitch. For example, whenthe sheath is initially being retracted, it may be desirable to move thesheath a greater amount for each rotation of the thumbscrew, thisprevents the medical device from “jumping” during deployment and enablesmore precise placement of the medical device within the patient'svasculature. After initial movement of the sheath, the thread pitch maybe changed to slow the movement of the sheath.

In accordance with another aspect of the invention, a rack-and-pinionassembly as shown in FIG. 11 can be used. Rack-and-pinion assembly 190includes a rotatable drive gear actuator 196, a first shaft 194connected to the drive gear actuator 196. In accordance with thisembodiment of the invention, shuttle 140 is attached to a rack 198. Rack198 can be formed into the outer surface 256 of hypotube 250. Thus,rotational movement of actuator 196 is translated into longitudinalmovement of shuttle 140 and sheath 90. Additionally, manual override 198a attached to rack 198 and/or sheath 90 can be provided, wherein theuser can push on override 198 to move the sheath. Other methods andmechanisms are also within the scope of the invention. For example,retraction device such as a handle or spool could be connected to sheathby way of a pull wire (not shown).

Similarly, sheath 90 could be retracted by using a system ofhydraulically or pneumatically controlled pistons. In further accordancewith the invention and as depicted in FIG. 12, a hydraulic system isdepicted for retracting sheath 90. In accordance with this aspect of theinvention, sheath 90 is affixed to a piston 191 having a seal 193 aboutits periphery. A supply of pressurized fluid 195, such as air or liquidsaline solution, can be brought into fluid communication with a distalface 197 of piston 191 by opening valve 199. When valve 199 is in anopen condition, the pressurized gas acts on distal face 197 of piston191, causing it to be displaced in a proximal direction. Additionally,sheath 90 could also be retracted by using electromagnetic solenoidsand/or drive motors.

In further accordance with another aspect of the invention, the deliverysystem includes a lock having an unlocked position permitting movementof the sheath, and a locked position prohibiting movement of the sheath.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIG. 13, a lock 200 is provided. The lock 200 preventsaccidental deployment of the medical device 400 by preventing movementof the sheath 90 with respect to inner member 10. As depicted in FIGS.1( a) and 13 lock 200 is provided in the form of an elongate memberhaving a proximal end 202, a distal end 204, a longitudinal groove 206and a knob 208 located at distal end 204. Lock 200 is installed andslidably disposed in a linear protrusion 182 in knob 180. Lock 200 has alocked position wherein the lock is engaged with a recess 214 in handle120. In this position, lock 200 prevents rotational movement of knob 180with respect to handle 120, and hence prevents longitudinal movement ofsheath 90 (or the actuator) with respect to inner member 10. Lock 200can be moved from its locked position in a distal direction with respectto handle 120 so that lock 200 disengages from recess 214 and is fullywithin the longitudinal length of knob 180. In this unlocked position,lock 200 no longer prevents rotational movement of knob 180 and thussheath 90 can be moved by actuating actuator thereby permitting movementof sheath 90. A user presses on knob 208 to disengage or engage lock200. In the unlocked position movement the sheath or the actuator ispermitted.

As embodied herein, lock 200 is attached to knob 180. When moved from alocked position to an unlocked position, lock 200 also serves as abearing surface for a user's thumb to facilitate rotational movement ofknob 180 with respect to handle 120.

In another embodiment of the lock of the invention, the lock operates ina similar fashion as describe above but includes a locking lever 850operationally engaged to the actuator and configured to releasably lockat least one of the actuator and sheath when in the locked position. Thelocking lever 850 is hingedly attached to the handle and also includes adetent 852, as depicted in FIGS. 21 a-21 d. The detent 852 engages theactuator and inhibits movement of the sheath. As embodied herein, thelock uses lever and/or cam action. As shown in FIG. 21 a, the lever 850is squeezed before the stent can be deployed. The lever 850 isconfigured to provide initial deployment of the stent once as it isactuated.

As depicted in FIGS. 21 a-21 d, the lock is operatively disposed toprovide initial movement of the sheath when the lock is moved from thelocked position to the unlocked position. The lock includes a cam tocooperate with the actuator to provide the initial movement.

In accordance with a preferred embodiment of the invention, lock 200 isformed of a polymeric or epoxy material containing approximately 20%fiberglass. However, other materials can be used. For example, ametallic material or other plastic or composite material may be used toform lock 200.

A variety of configurations can be used as a lock 200. For example, asliding plate configuration need not be used for lock 200. A pushbuttonlocking device or rotatable member could be used. Similarly, a frangiblemember could be used whereby the frangible member is ruptured when acertain threshold torque is exceeded. Lock 200 could also include a keymember (not shown) that would need to be inserted or removed in order topermit movement of the sheath 90.

In yet another alternative embodiment of the present invention, thehandle comprises a gear assembly, wherein the gear assembly providesmechanical amplification of a user's input. The mechanical amplificationcan be utilized to remove the sheath 90 from covering the stent 400 in anon-linear manner. For example, it may be desirable to slowly remove thesheath initially and then remove the sheath quickly after a portion ofthe stent has been delivered. Additionally, endoprosthesis' becomelonger the force necessary to retract the sheath increases, therebyrequiring more user applied force to deploy the stent which may lead tomisplacement or damage to the endoprosthesis. Therefore, it is desirableto provide a delivery system capable of quickly delivering these longerlength endoprosthesis'.

In accordance with another aspect of the invention, as depicted andembodied in FIGS. 17 a through 20 h, a delivery system includes anactuator on the handle and coupled to a rack-and-pinion assembly. Therack-and-pinion assembly is moves the sheath with respect to the innermember along the longitudinal axis from the first sheath position to thesecond sheath position. Further, the rack-and-pinion assembly isconfigured to increase the deployment rate of movement for the sheathduring at least a portion of movement of the actuator.

As depicted in FIGS. 17 a through 17 c, the rack-and-pinion assemblyincludes a first gear rack 298, a second gear rack 297 and a pinion gear296. The second rack 297 is disposed adjacent the first end of the firstrack 298 and at an angle relative thereto. For example and notlimitation, the first rack 298 is disposed at an angle less than ninetydegrees relative to the second rack 297. The first gear rack 298 ismoveable relative the second gear rack 297 and the pinion gear 296 isoperatively coupled to the first and second gear racks, respectively. Infurther accordance with one embodiment of the invention, the first gearrack 298 is coupled with the sheath 90 at its proximal end 94.

As depicted in FIG. 17 a through 17 c, each of the first rack 298 andthe second rack 297 include a plurality of gear teeth along a lengththereof, respectively. In one embodiment, the first rack 298 has adifferent number of teeth than the second rack 297.

As depicted herein, the first rack includes pins 291 configured to bereceived within a track provided on the handle 120. The pins 291 aredisposed adjacent to and perpendicular to the plurality of gear teeth.The pins 291 are configured to be received within grooves (not shown)formed in the handle 120 as previously shown, wherein the grooves definea path which the first rack 298 would travel along in use.

In a further aspect of the invention, the actuator can include a slider295, which is operatively coupled to the pinion gear 296. The slider 295is moveable in a linear direction. In accordance with one embodiment,slider 295 includes first and second extenders 299 extending therefrom.Each extender includes a slot 294 defined therein. As shown in FIG. 17a, each end 293 of the pinion gear 296 slidingly engages a respectiveone of the slots 294 defined in each of the first and second extenders299. Each of the first and second ends of pinion gear 296 can furtherinclude shaft 293 slidably disposed within the slot 294 and through anaxis of the pinion gear 296. The shaft 293 is configured to slide withinthe slot 294 and allow the pinion gear 296 to rotate.

As depicted in FIGS. 17A-C the first rack 298 is operatively coupled tothe pinion gear 296 and the plurality of gear teeth of the second rack297 operatively engage with the pinion gear 296. In this manner,movement of the slider 295 engages the pinion gear 296 along the secondgear 297 rack to rotate the pinion gear 296, which in turn engages thefirst gear rack 298 for linear movement thereof. In this regard, theengagement of the pinion gear 296 with the second rack 297 due to themovement of the slider 295 results in movement of the first rack 298 inthe linear direction at a rate greater than the movement of the slider295. The second rack 297 is fixedly attached to the housing 120 (notshown) and does not move during use. In accordance with an alternativeembodiment of the invention, the plurality of gear teeth disposed oneach rack have a different pitch, thereby providing a forceamplification system.

Preferably, as embodied herein, the second rack 297 includes a pair ofelongate members 292, as shown in FIG. 17 c. Each elongate member 292includes a plurality of teeth in engagement with the pinion gear 296.

In yet another aspect of the invention, as embodied herein and depictedin FIG. 17 a-18 c, a shuttle 240 is slidably disposed at the second endof the first rack. The shuttle 240 is connected to the proximal end 94of the sheath 90 as described herein.

As shown in FIG. 17 a, the two rack assembly is shown in an initialposition, wherein the distal end of the sheath 90 would be covering theseat 116 and the stent 400. To deploy the stent 400 from the seat 116, auser would apply a force to the slider 295, wherein the slider 295 wouldtranslate along an axis as indicated in FIG. 17 by line X-X. As theslider 295 translates along a length of the handle 120 while the piniongear 296 rotates. As the pinion gear 296 rotates, the first rack 298 istranslated and the pinion moves down the second rack 297 as shown inFIG. 17 b. Additionally, as the first rack is translated, the shuttle240 attached to the proximal end of the sheath 94 slides within thegroove 241 formed in the first rack 298.

Referring now to FIG. 17 c there is shown the rack-and-pinion assemblywherein the slider 295 has been translated to a final position and thesheath 90 has been removed from covering the seat 116 and the stent 400(not shown). As shown in FIG. 17 c, the first rack 298 and the pinion296 are disposed at the bottom of the second rack 297. In this regard,in operation, as shown in FIG. 17 a, the slider 290 is moved indirection A by a user. This results in the pinion gear 296 moving downthe second rack 297 in direction B, which in turn results in rotation ofthe pinion gear 296 in direction C. This draws the first rack 291direction D which results in the retraction of the sheath 94.

Preferably, and as embodied herein, the ratio of movement of the sheathto movement of the actuator can be greater than 1:1 during at least aportion of movement of the actuator. For the purpose of illustration andnot limitation, the rack-and-pinion assembly shown in FIGS. 17 a-17 cprovides the user with a two to one ratio, that is for every 1 cm theslider 295 is moved, the distal end of the sheath moves 2 cm. Thisincreased sheath retraction is desirable for retracting sheaths coveringlong stents.

In further accordance with the invention, the ratio of movement of thesheath to movement of the actuator can vary. Alternatively, however, theratio of movement of the sheath to movement of the actuator can beconstant, if desired.

In another embodiment of the invention, as shown and depicted in FIGS.18 a through 18 c, the rack-and-pinion assembly includes a second rack300 configured as a non-linear member. For example and not limitation,the non-linear member can be arc-shaped. In this manner, the second rack300 as embodied in FIGS. 18 a-18 c provides non-linear sheath movement.

As embodied herein, as a force is initially applied to the slider 295,the slider slides back in a channel formed in the handle 120 (notshown), wherein the pinion gear 296 rotates, causing the first rack 298to translate. As the pinion gear 296 rotates and the first rack 298translates, the pinion gear 296 advances along the arc of the secondrack 300. Initially, the pinion gear 296 and the first rack 298 slowlyadvance along the arc of the second pinion gear 300. As the pinion gear296 and first rack 298 continue to advance along the arc of the secondrack 300 the rotational speed of the pinion gear increases, therebyincreasing the translation speed of the first rack. Thus, therack-and-pinion handle assembly illustrated in FIGS. 18 a-18 c causesnon-linear sheath movement. Initially, the sheath will be slowlyretraced from covering the stent, wherein as the slider is advanced at aconstant rate, the sheath will be removed more rapidly without requiringchange of input from the user.

In accordance with other embodiments of the invention, as embodiedherein and depicted in FIGS. 19 a through 20 i, the delivery systemincludes a two-rack assembly for the delivery of a medical device. Aslider 402 is located on a handle 404 and is configured to move a sheath406 along a longitudinal axis from a first sheath position to a secondsheath position (not shown) thereby delivering a medical device. Theassembly includes two substantially round gears 401 sandwiching a pinion408 and the slider 402. The slider 402 is located on top of but detachedfrom the pinion 408. In The slider 402 and pinion 408 are eachconfigured to interact with the gears 401 so that the sheath 406 isretracted a distance greater than the distance that the slider 402 ismoved.

As embodied herein and as depicted in FIGS. 19 a-20 i, therack-and-pinion assembly includes a pinion 408 having a plurality ofteeth along its length and a rack gear 401 having a circumferentialsurface and being rotatable about a center axis. The pinion gear has afirst gear pitch 410 operatively coupled with the pinion 408 and asecond gear pitch 412 vertically displaced on a height of thecircumferential surface.

Preferably, the actuator 402 includes a slider 405 having an elongatesurface 403 with a plurality of teeth therealong. The plurality of teethof the slider 405 are operatively coupled to a second gear pitch 412 ofthe rack gear 401 for rotation of the rack gear 401 upon linear movementof the slider 405. In this manner, the different gear pitches allows thepinion 408 to be displaced a distance greater than the slider 405. Theratio of displacement depends on the ratio of the first and second gearpitches.

In one embodiment, as shown in FIGS. 19 a-19 b, the first gear pitch isdefined by a first generally cylindrical portion 410 of the rack gear401. The rack gear 401 has a first diameter and the second gear pitch isdefined by a second generally cylindrical portion 412 of the pinion gearhaving a second diameter. The first diameter is greater than the seconddiameter. Rotation of the rack gear 401 due to linear movement of theslider 405 results in a greater rate of movement of the pinion 408. Thepinion 408 is operatively coupled to the sheath 406.

In an alternative embodiment, as depicted in FIGS. 20 a-20 i, the rackgear 401 is a bevel gear that has a generally conical circumferentialsurface 412. The second gear pitch is varied along a height of theconical surface 412. The plurality of teeth of the slider 402 aredisposed at varied heights along the elongate surface 403. Linearmovement of the slider 402 results in varied engagement of the pluralityof teeth along the height of the circumferential surface 412 to vary therate a rotation of the rack gear 401 and the rate of movement of thepinion 408.

As shown in FIGS. 20 f, 20 g, and 20 h, the plurality of teeth of theslider vary in pitch along a length of the elongate surface 403.

As shown in FIGS. 19 a and 20 a, the rack-and-pinion assembly includes asecond rack gear 401 and the pinion 408 is disposed between the firstand second rack gear 401.

Referring now to FIGS. 19 a and 19 b, this assembly can be configuredusing gears that have two sections. Each of the two racks gears 401 hasa lower section 410 and an upper section 412 such that the upper section412 has a diameter smaller than the lower section 410. The thumb slide402 engages with the upper section 412 and the pinion 408 engages withthe lower section 410. The ratio of movement of the sheath 406 to thethumb slide 402 is greater than 1:1. The ratio can be 2:1, for example,if the upper section 412 has a diameter that is half of the diameter ofthe lower section 410.

The rack-and-pinion assembly of FIGS. 20 a-20 i is similar to that shownin FIGS. 19 a-b, wherein the same or similar reference numbers have beenutilized to describe the same or similar components.

In this embodiment, the round rack gears 401 are configured as bevelgears 401 as shown in FIG. 20 i. The bevel gears 401 have an upperportion 412 with variable gear spacing and a lower portion 410 with aconstant gear ratio. The lower portion 410 is configured to retract thesheath 406 and the upper portion 412 is configured to interact with thethumb slide 402. The thumb slide 402 also includes a nose portion 414with variable gear spacing to correspond with the variable gear spacingof the bevel gears 401. The variable gear spacing is configured toprovide the following ratios of sheath thumb slide 402 movement tosheath 406 retraction distance: less than one to one during positioningof the medical device, for example 1:1.25 as shown in FIG. 20 c;approximately one to one during a transition period as shown in FIG. 20d; and greater than one to one during and after deployment of themedical device, for example 2.5 to 1 as shown in FIG. 20 e.

In accordance with another aspect of the invention, a delivery system inaccordance with the invention can be provided further including astabilizer disposed about the inner member and extending from thehandle.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIGS. 1( a) and 14(a), a stabilizer 220 is providedhaving a proximal end 222, a distal end 224, an exterior surface 226,and an interior surface 228 with a lumen 230 defined therethrough.Stabilizer 220 is preferably a tubular member disposed about sheath 90and attached at its proximal end 222 to nose 210. Specifically, proximalend 222 of stabilizer can be fitted into an enlarged diameter portion214 of lumen 212 in nose 210. The two parts may be joined by adhesivebond, may be melted together, or connected in other various ways as areknown in the art including threaded connections, press fit connectionsand the like.

Stabilizer 220 is preferably a flexible member capable of at least onedegree of movement. For example, stabilizer 220 can be provided in theform of a coil spring or other flexible tubular member capable ofbending along its longitudinal axis upon the application of a transverseforce. Lumen 230 of stabilizer 220 is configured to permit sheath 90 topass freely therethrough. With reference to FIG. 14( c), the externalsurface 226 of stabilizer 200 can be configured to fit into a guidesheath 234 with an introducer valve 236 that has already been introducedinto a patient's lumen. The guide sheath 234 defines a lumen 238 thatpermits passage of delivery system 300. Introducer valve 236 providesfor a liquid tight seal optionally, an o-ring 239 or other seal can beprovided. Introducer valve 236 can also be provided in the form of apierced membrane that surrounds sheath 90 or stabilizer 220. The liquidtight fit between stabilizer 220 and guide sheath 234 thus does notimpede retraction of sheath 90 when actuator 130 is actuated. Thus, itis possible to introduce delivery system 300 into a patient, deliver amedical device 400 and withdraw delivery system 300 with minimal bloodloss to the patient. The stabilizer 220 may be constructed having alength proportional to the overall length of the delivery system 300. Ina preferred embodiment, the ratio between the stabilizer and the overalllength of the delivery system 300 is about 2:1.

In an alternative embodiment depicted in FIG. 14( b), stabilizer 220 canhave an adjustable length. In accordance with this aspect of theinvention, stabilizer has a distal reduced diameter portion 221 that isslidably received in a proximal, increased diameter portion 223. Afixation member 225 can also be provided to fix the position of the twoportions 221, 223 of stabilizer 220 with respect to each other.Optionally, distal portion 221 can be threadably received in proximalportion 223. In accordance with this aspect of the invention, portions221, 223 can be provided in the form of concentric coil springs wherethe pitches are chosen such that one is threadably received inside ofthe other. It is further contemplated that the distal reduced diameterportion 221 may be utilized independently of the increased diameterportion 223.

Stabilizer 220 may be made from a metallic material such as stainlesssteel, but other materials can be used. For example, stabilizer can beof a braided shaft design, a multi-layer design, or other polymericextrusion.

Additionally or alternatively, a strain relief (not shown) disposedabout the stabilizer 220 can be provided. The strain relief isconfigured to reduce the stress concentration at the juncture betweenthe stabilizer 220 and the nose 210. Such a strain relief is made, forexample, from HS 101 irradiated polyolefin that can be obtained fromInsultab, Inc., although any suitable material of construction can beused.

In accordance with an additional aspect of the invention, the deliverysystem can be configured such that the sheath and inner member define anannular space therebetween, wherein the annular space is arranged influid communication with a flush port to permit a fluid to passtherethrough.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIG. 2, flush port 240 is arranged to be in fluidcommunication with the annular space 242 defined between the outersurface 60 of bumper 50 and the inner surface 102 of sheath 90. Shuttle140 is sized and shaped to be received by recess 134 in nosepiece 132.O-rings 158 are configured to provide a liquid-tight seal betweenshuttle 140 and wall portion 136 of recess 134 when a liquid is flushedthrough flush port 240. In addition, a shuttle flush lumen 149 (SeeFIGS. 1( d) and 2) is provided to permit fluid to pass through outerspace 243 shuttle to access annular space 242. When a fluid agent, suchas saline, is flushed through flush port 240 and annular space 244,o-rings 158 prevent the saline fluid from moving past shuttle 140 intohandle 120. A hose 246 can also be attached to flush port 240,preferably by way of adhesive connection, although other joiningtechniques are appropriate.

In accordance with another embodiment of the invention, a flush port 240can also be fitted onto proximal end 12 of inner member 12 (See FIG.12). Such a flush port can be used for flushing lumen 18. Such a flushport can further include an adaptor (not shown) in fluid communicationwith the lumen.

Flush port 240 can take on a variety of forms. In accordance with analternative embodiment of the invention, Flush port 240 can be providedwith a non-return valve. In accordance with this aspect of theinvention, a non-return valve (not shown) can be attached to flush port240 to permit a positively pressurized stream of flushing fluid (e.g.,saline solution) to pass through flush port 240, but prevent air frompassing into flush port 240 after the stream of flushing fluid isdisconnected. The non-return valve can be, for example, a check valvethat includes an elastic member biased to keep the valve in a closedcondition. The elastic member can be provided in the form of a spring.Alternatively, a membrane of elastic material containing an orificecould be used, whereby a positively pressurized fluid can pass throughthe orifice but air at atmospheric pressure cannot. Such a non-returnvalve is preferably used to direct a beneficial agent though channel 53of device 300 to a predetermined location in a patient.

An alternative embodiment of the nose 210 can be seen in FIG. 16,wherein the nose 1210 as illustrated in FIG. 16 includes a flush port1240. Nose 1210 further includes a valve 1211 wherein the valve 1211eliminates the o-rings 158 of the shuttle assembly, thereby reducingfriction within the system. As shown in FIG. 16, the flush port 1240 isconfigured to directly receive the distal end of a syringe, for example,the flush port 1240 may be constructed having geometry similar to thatof a luer fitting, thereby allowing the delivery system to be flushedwith the use of a conventional syringe.

In further accordance with the invention, the delivery system canfurther include a hypotube 250 disposed about the inner member 10.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIGS. 1( d) and 2, hypotube 250 has a proximal end 252, adistal end 254, an outer surface 256, and a lumen 148 definedtherethrough. As embodied herein, hypotube 250 is disposed about innermember 10. Distal end 254 of hypotube 250 is proximal to the proximalend 52 of the bumper 50. Proximal end 252 of hypotube 250 is adjacent todistal end 276 of adjustment hypotube 272, discussed in detail below.Hypotube 250 may be made of a metallic material, but may also be madefrom a polymeric material or may be a resin-impregnated fiber reinforcedmember.

Hypotube 250 is preferably connected near its proximal end 252 to aconnector 260. Connection may be achieved, for example, by way ofadhesive bond, threaded or keyed connection, force fit, or the like.Connector 260, in turn, is in abutting relationship with proximal end172 of thumbscrew 170, such that thumbscrew 170 can rotate with respectto connector 260.

Connector 260 is preferably made from a plastic material such as ABSplastic, but may also be made from other polymeric or metallicmaterials.

In accordance with a representative embodiment of the invention,hypotube 250 has a length of about 1.6 inches, an external diameter ofabout 0.065 inches and an inside diameter of about 0.05 inches. Hypotube250 may be made from stainless steel, although other materials can beused. For example, plastic materials and/or composite materials such assingle or multilayer extrusions can be used. It will be understood thatdimensions can vary depending on the intended use of delivery system300.

In further accordance with the invention, a medial portion 121 of handle120 including gripping surface 126 can be attached onto connector 260,preferably by way of adhesive bond. As depicted in FIG. 2, an externalthreading 262 is provided on connector 260 to provide an attachmentpoint for complementary threading 123 on medial portion 121 of handle120, although other joining techniques can be used, such as adhesivebonding, solvent welding and the like.

The delivery system in accordance with the invention also can include anadjustment member configured to move the inner member with respect tothe sheath.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIG. 2, adjustment member 270 includes an adjustmenthypotube 272 disposed about the proximal end 12 of inner member 10.Adjustment hypotube 272 is preferably attached to inner member 10 andhas a proximal end 274 and a distal end 276. Adjustment member 270 canfurther include a hub 278 fixedly attached to the proximal end 274 ofthe adjustment hypotube 272. Distal end 276 of adjustment hypotube 272is disposed adjacent hypotube 250. Adjustment hypotube may be made ofmetal, but also may be made from a polymeric of fiber-reinforced resinmaterial.

In further accordance with the invention, the adjustment member caninclude an adjustment lock where the adjustment lock has a lockedposition to prevent the inner member from being displaced longitudinallywith respect to the sheath and an unlocked position to allow the innermember to be displaced longitudinally with respect to the sheath.

For purposes of illustration and not limitation, as embodied herein andas depicted in FIG. 2, adjustment lock 280 is provided. Adjustment lock280 can be provided at proximal end 122 of handle 120. As embodiedherein, adjustment lock is provided in the form of a body having acollet 282 (not shown) that is threaded into threads 125 located atdistal end 124 of handle 120. In operation, when adjustment lock 280 isin a locked position, collet 282 clamps down on adjustment hypotube 272,and adjustment member 260 and inner member 10 cannot move longitudinallywith respect to sheath 90 without actuating actuator 130. However, whenadjustment lock 280 is in an unlocked position, relative movementbetween inner member 10 and sheath 90 can be achieved without actuatingactuator 130. In this manner, small adjustments can be made by aphysician to align sheath 90 with tip 30 before use of delivery system300. Such adjustments can be necessary if inner lumen 10 elongates inthe process of sterilization.

For purposes of illustration and not limitation, as depicted in FIG. 15,in further accordance with the invention, when delivery system 300 isprovided with more than one seat 116 to permit delivery of more than onemedical device 400, adjustment member 270 (see FIG. 2) can be used torealign the distal end 98 of sheath 90 with tip 30 after a medicaldevice has been delivered. For example, after a first medical device,such as a stent 400 a, is delivered, seat 116 a is exposed, and sheath90 is still covering medical device 400 b. By unlocking adjustment lock280, inner member 10 and tip 30 can move longitudinally with respect tosheath 90, bumper 50 b-n, and medical device 400 b. Inner member 10 isthen moved in a proximal direction with respect to sheath 90. In theprocess, bumper 50 a, which is preferably freely disposed over innermember 10, is urged against medical device 400 b, and the distal end 98of sheath 90 is brought into contact with tip 30, and the adjustmentlock 280 is locked to prevent bumpers 50 a-50 n and medical devices 400b-400 n from moving with respect to sheath 90 or inner member 10.Delivery system 300 can then be displaced to a different location withinthe patient to deliver subsequent medical devices 400 b-400 n. Theability to deliver multiple medical devices without removing deliverysystem 300 from the patient can decrease the total amount of timenecessary for the medical procedure. This arises from eliminating theneed for preparing and introducing multiple delivery systems to thepatient. In addition, introducing a single delivery system into apatient instead of multiple devices also reduces trauma to the patient.

Moreover, in the embodiment of the invention in FIG. 15, it would alsobe possible to equip each bumper 50 a-50 n with channels 53 a-53 n (notshown) as described in detail above to direct a beneficial agent to apredetermined location in a patient. Thus, each time a medical device400 a-400 n is delivered, it is possible to direct a beneficial agentthrough channels 53 a-53 n and/or via material deposited in perforations64 in each bumper segment 50 a-50 n. An agent to release beneficialagent in perforations 64 can additionally or alternatively be introducedthrough flush port 240 and directed through channels 53 a-53 n to apredetermined location in a patient.

In further accordance with the invention, the delivery system alsoincludes a method of assembling a delivery system for delivering amedical device. The method includes providing a sheath, providing abumper, positioning the bumper into the sheath, providing a medicaldevice, disposing the medical device in the sheath, providing an innermember having a tip formed at a distal end thereof, placing the innermember through the medical device and the bumper, and positioning ahandle over the inner member. For purposes of illustration and notlimitation, reference will be made to a method of assembling thedelivery device of FIG. 1 described in detail above.

As embodied herein, the method includes providing a sheath such assheath 90 depicted herein. However, other types of sheaths may be used.For example, although a bendable sleeve type member has been depictedherein, other forms of sheaths, including sheaths that peel away from amedical device and sheaths that fold over onto themselves when a distalend thereof is pulled proximally may be used.

The method also includes, providing a medical device and disposing themedical device in the sheath. As previously mentioned, different typesof medical devices 2 can be provided in accordance with the method ofthe invention.

When the medical device 400 is provided in the form of a self-expandingstent, the stent is compressed from an expanded state to a compressedstate for loading by crimping the stent in a stent-crimping machine.This may be accomplished, for example, by stretching out the distal end98 of sheath 90 with tweezers, and positioning distal end 98 into thestent crimping machine so that the machine grips the distal end 98 ofsheath 90. The stent crimping machine then crimps the stent and advancesit proximally into the distal end 98 of sheath 90. After the stent hasbeen loaded, the stretched out portion of the distal end 98 is thentrimmed off. The distal end 98 of sheath 90 is provided without areinforcing layer 114. This is particularly advantageous where thedistal end 98 is stretched out to load the stent as described above.Moreover, the medical device disposing step includes placing the medicaldevice 400 into the distal end of the sheath. The medical devicedisposing step preferably occurs after the bumper positioning step, asdescribed below. It is further contemplated that the medical device 400may be coated with a lubricious coating such as silicone oil or the likeprior to crimping, thereby reducing frictional forces between themedical device and the crimping device as well as frictional forcesbetween the medical device and the sheath. Additionally, the lubriciouscoating may reduce frictional forces during deployment of the medicaldevice.

The method further includes the steps of providing a nose and placingthe sheath through the nose, if desired.

In accordance with this aspect of the invention, sheath 90 is placedthrough a nose 210 of a handle 120 that is provided, as described above.Preferably, the sheath 90 is placed through the nose 210 prior topositioning the bumper 50 in the sheath 90, as described below. Inaccordance with another aspect of the invention, the nose providing stepadditionally includes the steps of providing a stabilizer such asstabilizer 220 and disposing stabilizer 220 on nose 210, if desired.

Even more preferably, if a rotatable actuator is to be provided, shuttle140 is positioned on the sheath 90 prior to placing the sheath 90through the nose 210. In this manner, the method further includes thestep of positioning the shuttle 140 into a guide member such as shuttleguide 160 as depicted herein.

In further accordance with the invention, the method includes providinga bumper and positioning the bumper into the sheath. For purposes ofillustration and not limitation, a bumper such as bumper 50 describedherein may be provided. The bumper positioning step further includes thestep of positioning bumper 50 into the distal end 98 of the sheath 90.Other variations of bumper 50 described herein are also appropriate forthe bumper positioning step.

Additionally, the bumper providing step includes the steps of providinga sleeve member 51 having a cylindrical wall 56, providing a proximalradiopaque portion 76, and placing the proximal radiopaque portion 76 onthe sleeve member 51. Proximal radiopaque portion 76 can take variousforms, as described in detail above. The bumper providing step alsoincludes the steps of providing a covering member 80 as described indetail above, and disposing covering member 80 on sleeve member 51 andproximal radiopaque portion 76 of bumper 50, if desired.

In still further accordance with the invention the method furtherincludes providing an inner member and placing the inner member throughthe medical device and the bumper.

For purposes of illustration and not limitation, the inner memberplacing step generally provides for placing inner member 10 throughmedical device 400 and bumper 50. Preferably, the inner member placingstep occurs after disposing bumper 50 in sheath 90. Even morepreferably, the proximal end of the inner member 10 is inserted in thedistal end of the sheath.

The inner member placing step also includes positioning the proximal end12 of the inner member 10 through the medical device 400 and the bumper50. This is particularly appropriate in the situation where the methodalso includes the steps of providing a tip 30 and positioning the tip 30on the distal end 14 of the inner member 10. In this situation, theproximal end 12 of inner member 10 is the only end of inner member 10that is placed through medical device 400 and bumper 50 since tip 30 hasalready been attached. The tip providing step can further include thesteps of providing a distal radiopaque portion 40 and placing theradiopaque portion on the tip 30. The method can also include the stepof annealing the inner member, as described in detail above.

In further accordance with the invention, the method further includesthe step of positioning a handle over the inner member.

For purposes of illustration and not limitation, a handle 120 asdescribed in detail above may be provided. In accordance with thisaspect of the invention, the handle positioning step includes the stepsof providing a thumb screw assembly. The thumb screw assembly 188 ofthis embodiment includes, for example, a knob 180 and a thumb screw 170.The thumb screw assembly 188 is further positioned on nose 210. Thehandle positioning step also includes disposing a lock 200 on the thumbscrew assembly 188 as described in detail above. The lock 200 preferablysnaps into place.

In accordance with another aspect of the invention, the method alsoincludes the step of positioning a hypotube over the proximal end of theinner member.

For purposes of illustration and not limitation, as embodied herein,hypotube 250 is positioned over the proximal end 12 of inner member 10.In accordance with this aspect of the invention, a connector 260 asdescribed above is also provided, disposed coaxially over hypotube 250.The method further includes the step of attaching connector 260 tohypotube 250 by way of an adhesive or other connection.

In accordance with another aspect of the invention, the method furtherincludes the step of applying a lubricious material to the distal end 98of sheath 90. In accordance with this aspect of the invention, thelubricious material application step preferably occurs when insertingthe inner member placing step. For example, when inserting proximal end12 of inner member 10 through medical device 400 and bumper 50 (wheremedical device 400 and bumper 50 already having been disposed in sheath90), a small gap (such as two inches in length) is maintained betweenproximal end 32 of tip 30 and distal end 98 of sheath. A small amount oflubricant (e.g., two drops of liquid silicone oil) is then applied todistal end 98 of sheath 90. Other suitable liquid lubricants can also beused. A pressurized fluid is then applied to the distal end of thesheath to cause the lubricious material to coat the medical device 400.This step is achieved, for example, by installing a force air fixtureover distal end 98 of sheath 90. The force air is activated, and thesilicone oil or other lubricant can be seen to migrate along medicaldevice 400, provided that distal end 98 of sheath 90 is made from atransparent material.

In a preferred embodiment, the method further includes the steps ofproviding an adjustment member 270 configured to move the inner member10 with respect to the sheath 90 and disposing the adjustment member 270on the inner member 10. The adjustment member disposing step preferablyincludes positioning the adjustment member 270 on the proximal end 12 ofthe inner member 10.

In further accordance with the invention, the method includes the stepof applying tension to the inner member.

For purposes of illustration and not limitation, as embodied herein,tension is applied to the proximal end 12 of the inner member 10 tocause the distal end 98 of the sheath 90 to come into physical contactwith proximal end of tip 30. The tension applying step is performedafter disposing adjustment member 270 over inner member 10, but beforeattachment of adjustment member 270 to inner member 10. Beforeattachment of adjustment member 270 to inner member 10, it should beverified that proximal end 32 tip 30 is properly aligned with distal end98 of sheath 90 and that distal radiopaque portion 40 is flush andaligned with medical device 400. Preferably, thumb screw assembly 188 ispositioned over inner member prior to attaching adjusting member toinner core 10, although handle 120 is assembled and attached to deliverysystem 300 at a later stage if properly configured. Tension may beapplied again by the physician upon receipt of the delivery system ifinner member 10 lengthens during sterilization or shipping by unlockingadjustment lock 280, and moving adjustment hypotube 272 proximally tobring proximal end 32 of tip 30 into contact with distal end 98 ofsheath 90. The method steps need not be practiced in any particularorder. The method of the invention can be modified as needed to suit aparticular purpose, depending at least in part on the finalconfiguration of the delivery system. For example, handle 120 could beconfigured so that it is installed last, or thumb screw assembly 188could be configured such that it is installed after connector 260 isinstalled.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the device, method andsystem of the present invention without departing from the spirit orscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

1. A delivery system for delivery of a medical device, the deliverysystem comprising: an inner member having a proximal end and a distalend, the inner member defining a longitudinal axis therebetween; a tipdisposed at the distal end of the inner member; a bumper disposed on theinner member, the bumper having a proximal end and a distal end, a seatbeing defined between the tip and the distal end of the bumper; a sheathdisposed about the inner member, the sheath having a proximal end and adistal end, the sheath being movable from a first sheath positionsubstantially covering the seat, and a second sheath position axiallyoffset to expose the seat; a handle connected to the proximal end of theinner member; and an actuator on the handle to move the sheath withrespect to the inner member along the longitudinal axis from the firstsheath position to the second sheath position, the actuator including afirst adjust element operatively coupled to a first gear to provide afirst deployment rate for movement of the sheath and a second adjustelement operatively coupled to a second gear to provide a seconddeployment rate for the movement of the sheath, the first deploymentrate being different than the second deployment rate wherein at leastone of the adjust elements is moveable independently of the other adjustelement.
 2. The delivery system of claim 1, wherein the first deploymentrate is greater than the second deployment rate.
 3. The delivery systemof claim 1, wherein the first gear is a sun gear.
 4. The delivery systemof claim 1, wherein the second gear is at least one planetary gear. 5.The delivery system of claim 4, wherein three planetary gears areprovided.
 6. The delivery system of claim 1, wherein the first adjustelement is a course adjust element and the second adjust element is afine adjust element.
 7. The delivery system of claim 6, wherein thecourse adjust element is a thumbscrew.
 8. The delivery system of claim1, wherein the actuator is configured to move the sheath from the firstsheath position to the second sheath position at a ratio greater thanone to one.
 9. The delivery system of claim 8, wherein the ratio of thefirst gear and the second gear is 3:1.
 10. The delivery system of claim8, wherein the ratio of the first gear and the second gear is 2:1. 11.The delivery system of claim 1, wherein the inner member is a tubularmember having a proximal end, a distal end, and a length therebetween;the bumper including a sleeve member, the sleeve member having a lengthand a tubular wall; the sleeve member being formed of a flexiblemetallic element disposed along at least a portion of the length of theinner member.
 12. The delivery system of claim 11, wherein the bumperfurther includes an outer layer over at least a portion of the flexiblemetallic element.
 13. The delivery system of claim 12, wherein the outerlayer is formed from a polymeric material.
 14. The delivery system ofclaim 11, wherein the bumper defines a first portion along the length ofthe inner member having a first diameter and a second portion along thelength of the inner member having a second diameter, the first diameterbeing greater than the second diameter.
 15. The delivery system of claim14, wherein the first diameter is defined by the inner member and bumpercombined, and the second diameter is defined by the inner member. 16.The delivery system of claim 15, wherein the second diameter defines theseat.
 17. The delivery system of claim 15, wherein the inner memberdefines a guidewire lumen along a length thereof.
 18. The deliverysystem of claim 17, wherein the inner member is formed of a lubriciousmaterial.
 19. The delivery system of claim 11, wherein the flexiblemetallic element is a braid or coil element.
 20. The delivery system ofclaim 11, wherein the bumper is freely disposed on the inner member. 21.The delivery system of claim 11 further comprising a hypotube disposedabout the inner member, the hypotube having a distal end and a proximalend, the distal end of the hypotube being proximal to the proximal endof the flexible metallic element.
 22. The delivery system of claim 1,wherein the distal end of the bumper is configured to receive andradially constrain a proximal end of a stent disposed within the seat.23. The delivery system of claim 22, wherein the distal end of thebumper includes a conical configuration.
 24. The delivery system ofclaim 22, wherein the distal end of the bumper includes substantiallyrigid projections.
 25. The delivery device of claim 1, wherein thesheath includes an inner surface and an outer surface defining a wallthickness therebetween, the wall thickness being greater at the distalend than the proximal end.
 26. The delivery device of claim 25, whereinthe wall thickness is tapered between the distal end and the proximalend.
 27. The delivery system of claim 1, wherein the sheath includes anouter wall and a liner, the liner having an inner surface and an outersurface defining a wall thickness therebetween, the wall thickness beinggreater at the distal end than the proximal end, the outer surface ofthe liner being secured to an inner surface of the outer wall.
 28. Thedelivery system of claim 27, wherein the inner surface of the liner islubricious.
 29. The delivery system of claim 1, further comprising alock having an unlocked position permitting movement of at least one ofthe actuator and sheath, and a locked position prohibiting movement ofthe at least one of the actuator and sheath.
 30. The delivery system ofclaim 29 wherein the lock includes a locking lever operationally engagedto the actuator and configured to releasably lock at least one of theactuator and sheath, when in the locked position.
 31. The deliverysystem of claim 29, wherein the lock is operatively disposed to provideinitial movement of the sheath when the lock is moved from the lockedposition to the unlocked position.
 32. The delivery system of claim 29,wherein the lock includes a cam to cooperate with the actuator toprovide the initial movement.
 33. The delivery system of claim 29,wherein the locking lever is hingedly attached to the handle and furtherincludes a detent configured to engage the actuator to inhibit movementof the sheath.
 34. The delivery system of claim 1, wherein the tipincludes a stent retention feature, the retention feature including arecess to receive and radially constrain a distal end of a stentdisposed in the seat.